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Placebo (100 ml)
Placebo (100 ml) is a Small molecule drug developed by R-Pharm. It is currently in Phase 3 development.
This drug has no known mechanism of action.
Placebo (100 ml) is a small molecule intervention used as a control in clinical trials, including studies on cardiogenic shock, endothelial dysfunction, postoperative pain management, fractures, and dislocations. It is a placebo used in a randomized, double-blind, multi-center trial to assess the efficacy and safety of Adrecizumab in subjects with cardiogenic shock.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Placebo (100 ml) |
|---|---|
| Sponsor | R-Pharm |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
As a placebo, it does not contain any active pharmaceutical ingredient and therefore does not have a known mechanism of action.
Approved indications
Common side effects
Key clinical trials
- A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT) (PHASE2)
- A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE) (PHASE3)
- Effects of Different Caffeine Forms on Aerobic and Anaerobic Exercise Performance (NA)
- A Study of V940/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) (PHASE2)
- Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy (PHASE2)
- Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy (NA)
- Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing (PHASE2)
- Stem Cells for Erectile Dysfunction Post RALP (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo (100 ml) CI brief — competitive landscape report
- Placebo (100 ml) updates RSS · CI watch RSS
- R-Pharm portfolio CI
Frequently asked questions about Placebo (100 ml)
What is Placebo (100 ml)?
How does Placebo (100 ml) work?
Who makes Placebo (100 ml)?
What development phase is Placebo (100 ml) in?
Related
- Manufacturer: R-Pharm — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing